Kornimate/medical-research-clean huggingface dataset:
migraine headache mitigation utilizing avulux

Conditions: Migraine; Headache; Photophobia

Summary: this will be a randomized double blind cross over interventional trial to determine if avulux lenses are able to reduce headache symptoms in patients

participants: this study will include a total of 40 participants aged 18 and over who have been screened for migraine headache history. patients who attended the sbc headache class with a diagnosis of migraine from the last 12 months will be selected and assigned a number. random number set will be used to select the 40 patients. additional 40 patients will be selected to meet the total initial enrollment of 40 patients in the end. these 40 patients will be randomly assigned to avulux or control groups. each patient will be assigned a unique identifier, and the rest of the correspondents will not use patient demographics. design: the study will be a randomized, double blind, crossover interventional trial. participants will be randomly assigned to one of 2 groups of 20. 1. experimental group: participants in this group will wear avulux lenses during the testing sessions. 2. control group: participants in this group will wear placebo lenses that resemble avulux lenses but do not have the same optical properties. procedure: participants will complete a baseline assessment and self-report migraine frequency using the redcap migraine diary application. participants will complete testing sessions with both avulux and placebo lenses for the duration of 3 months and then switch lenses for the remaining 3 months for comparison and a total study period of 6 months.

Eligibility criteria:
inclusion criteria: * patient population: individuals must have an existing diagnosis code of g43.1 (migraine w aura) or g43. 10 (migraine w aura, not intractable). * only kaiser permanente members receiving care at the fontana medical service areas will be in consideration. * patients that are \>18 * there will no restrictions based on biological sex. * participants will be referred to optical by provider (neurologists/optometrist/primary care physician). * participants must agree to not initiate any new medical management during the trial or be willing to voluntarily withdrawal from participating in the trial exclusion criteria: * patients who do not have a migraine diagnosis code in their medical record. * patients that have started a new migraine medication within last 30 days * non-members of kaiser permanente
liposomal sirolimus in dry eye disease

Conditions: Dry Eye

Summary: dry eye disease is a very frequent pathology that importantly affects the quality of life of patients; in spite of the common use of eye lubricants to ameliorate symptoms, there is still a large number of patients who do not present improvement of the disease or they worsen. although its etiology is varied, the imbalance of the immune system plays a substantial role in the development of dry eye disease. rapamycin or sirolimus is an anti-inflammatory and immunomodulatory drug that has an enormous potential in ocular surface pathologies such as dry eye disease. the aim of the present study is to determine the effectiveness and security of subconjunctival application of a new formulated drug of liposomal sirolimus in patients with moderate and severe dry eye disease. this is a randomized placebo-controlled double blind clinical trial. patients presenting data of moderate or severe dry eye disease will be randomized into two groups. one group will receive additional to the conventional treatment, subconjunctival injections of liposomal sirolimus; meanwhile the other group will receive subconjunctival placebo injections. after intervention the effectiveness and the security of the liposomal sirolimus will be evaluated.


Eligibility criteria:
inclusion criteria: * subjects with moderate or severe dry eye * subjects with osdi score \> 22 * subjects with van bijsterveld staining score \>4 * subjects that accept to participate in the study exclusion criteria: * subjects with refraction surgery antecedents * subjects with ophthalmic surgery six months previous to the study * subjects with lagophthalmos * subjects with facial paralysis antecedents * subjects with herpetic keratitis * subjects using isotretinoin * pregnant subjects * subjects in lactating period * subjects with allergy or intolerant to the drug * subjects with hepatic disorders * subjects with abnormal thoracic x rays

Keywords: sirolimus liposomal subconjunctival
management of csdh with or without emma- a randomized control trial

Conditions: Chronic Subdural Hematoma

Summary: emma-can is an open-label randomized control trial comparing the recurrence risk in patients with chronic subdural hematoma (csdh) undergoing standard of care treatment (surgical drainage and/or medical management) with or without embolization of the middle meningeal (emma).

all patients in clinical need of surgical drainage or medical management for the csdh will be randomized in our study. patients that present in the emergency department (ed) or neurosurgery clinic will be assessed for standard of care treatment options based on their presenting symptoms; this may include surgical drainage or medical management. patients will then by screened for study eligibility based on the study inclusion and exclusion criteria. after screening and consenting patients will be randomized in to the control arm or interventional arm. patients randomized to the control arm will undergo institutional standard of care treatment (surgical drainage and/or medical management) of the csdh. patients randomized to the interventional arm will undergo institutional standard of care treatment (surgical drainage and/or medical management) of the csdh as per the standard of care in the institution. these patients will then undergo emma within 48 hours after finishing the surgical drainage. the embolic agent and use of general anaesthesia versus conscious sedation will be left to operators' preference and the institutional protocol. all patients will be followed as per the institutional standard of the care. any peri-procedural complications and change in clinical status will be recorded. the risk of recurrence at 90-days in patients who undergo standard of care treatment (surgical and/or medical management) of csdh with or without emma will be observed.

Eligibility criteria:
inclusion criteria: 1. modified rankin scale of ≤2 at baseline 2. patients requiring surgery or has at least 10 mm of csdh on ct head and has one or more symptoms attributable to csdh, including headache, cognitive impairment, ataxia, seizure, focal neurologic deficit, or decreased consciousness. 3. ct angiogram of head and neck which favors vascular access for emma and lacks dangerous anatomic variations. exclusion criteria: 1. if informed consent can not be obtained from the patients or their substitute decision makers. 2. ct angiogram showing dangerous communication between middle meningeal artery and branches of internal carotid arteries. 3. contraindication to the embolization procedure such as severe renal dysfunction, or pregnancy 4. life expectancy \< 6 months. 5. known allergy to embolic agent 6. acute subdural hematoma with homogenous hyperdensity on ct scan. 7. secondary csdh that may likely be due to the underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or prior craniotomy.

Keywords: chronic subdural hematoma, middle meningeal embolization
iron in patients with cardiovascular disease

Conditions: Cardiovascular Diseases; Anemia, Iron-deficiency; Acute Myocardial Infarction; Atrial Fibrillation; Systolic Heart Failure

Summary: it is now recognized that iron deficiency in cardiovascular disease contributes to impaired clinical outcome.

the clinical trial is designed as a prospective, multi-centre, double-blind, randomised, controlled, interventional trial to investigate whether a therapy with i.v. iron (iron carboxymaltose) compared to saline can improve functional status across a subset of cardiovascular disease -namely acute myocardial infarction, atrial fibrillation, and heart failure with reduced ejection fraction. iron administration will be carried out according to summary of product characteristics. bolus administration (1000 mg) will be followed by an optional administration of 500-1000 mg within the first 4 weeks (up to a total of 2000 mg which is in-label) according to approved dosing rules, followed by administration of 500 mg iron carboxymaltose (over 15 minutes), except when haemoglobin is \> 16.0 g/dl or ferritin is \> 600 µg/l.

Eligibility criteria:
inclusion criteria: 1. cohort a (acute myocardial infarction): acute myocardial infarction within 10 days (randomization/ first iron supplementation/ mri must be performed within 10 days after ami), without prior heart failure (defined as any known previous report of lvef ≤ 45%) cohort b (atrial fibrillation): paroxysmal atrial fibrillation or persistent af cohort c (heart failure): left-ventricular ejection fraction ≤ 45 % (documented within the last 12 months prior to screening), all nyha classes allowed 2. confirmed presence of iron deficiency (ferritin \< 100 ng/ml or ferritin 100 - 299 ng/ml with transferrin saturation \< 20 %) 3. haemoglobin ≤ 15.5 g/dl 4. written informed consent exclusion criteria: 1. evidence of iron overload or disturbances in the utilisation of iron 2. history of severe asthma, eczema or other atopic allergy 3. history of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis) 4. use of renal replacement therapy 5. treatment with an erythropoietin stimulating agent (esa), any i.v. iron and/or a blood transfusion in the previous 4 weeks prior to randomisation.

Keywords: iron deficiency atrial fibrillation acute myocardial infarction systolic heart failure anemia
study on allopregnanolone and depression in women across the menopause transition

Conditions: Depression

Summary: this study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.

midlife women are burdened with depression risk that is at least partly attributed to changing reproductive steroid dynamics across a prolonged reproductive transition. we hypothesize that declining endogenous allopregnanolone (allo) levels across the menopause transition underlies perimenopausal depression. this mechanistic trial aims to amplify the contrast between lower endogenous allo levels in perimenopausal women and higher levels induced by pregnenolone. this will be achieved by using the over-the-counter dietary supplement, pregnenolone, in a randomized, double-blind, parallel-arm, placebo-controlled trial. by manipulating allo levels together with key measurement of depression domains, this study harnesses the endocrine biology of perimenopause to explicate behavioral and neurobiological mechanisms underlying depression in women across the menopause transition.

Eligibility criteria:
inclusion criteria: * healthy women ages 40 to 60 years in the menopause transition * depressive symptoms * psychotropic medications are allowed if the dose is stable prior to screening and throughout the study * able to read arabic numerals and perform simple arithmetic * able to provide written informed consent exclusion criteria: * systemic hormone therapy * contraindicated medications with pregnenolone * systemic corticosteroid * other psychiatric illnesses that are considered to be primary * current suicidal ideation * active substance use disorders * unstable medical conditions * obstructive sleep apnea or other primary sleep disorders * abnormal hepatic and renal function * known allergy to progesterone, exogenous allopregnanolone, or pregnenolone * history of head injury resulting in loss of consciousness \> 20 min * inability to comply with barrier contraceptive methods * known intellectual disability * investigator judgement that study participation constitutes substantial risk given medical or psychiatric condition * current or recent participation in clinical trial expected to interfere with risk of or interpretation of study data * inability to comply with study procedures
machine learning for identification of future disease development: a nationwide cohort study (milestone)

Conditions: Cardiovascular Disease; Metabolic Disease

Summary: to develop machine learning algorithms for the identification of future development of cardiovascular and metabolic disease

the milestone trial is retrospective and data review study with health checkup data from the national health insurance services(nhis) in korea. the data will be included general health examination for individuals , type of health insurance, medical bill details, medical histories, treatment and prescriptions about 514,795 individuals who were over 40 years old.

Eligibility criteria:
inclusion criteria: * the subject who is got health checkup between 2002 and 2013, and had been recorded the health checkup result to the national health insurance service(nhis) in south korea. exclusion criteria: * persons whose disease development is not identified from the records due to emigration or disappearance

Keywords: machine learning cohort study
early ino for oxidative stress, vascular tone and inflammation in babies with hypoxic respiratory failure

Conditions: Persistent Fetal Circulation Syndrome; Hypertension, Pulmonary, of Newborn, Persistent; Persistent Pulmonary Hypertension of Newborn

Summary: the investigators in this study are concerned about the harmful effects of oxygen exposure in newborn infants, particularly at high concentrations. inhaled nitric oxide (ino) is an fda approved drug for the treatment of hypoxic respiratory failure (hrf) in term and late-preterm babies greater than 34 weeks gestation. hypoxic respiratory failure occurs when a patient's lungs cannot get enough oxygen into their bloodstream. this condition is traditionally treated with high concentrations of oxygen and most often requires the patient be placed on a ventilator (breathing machine). the administration of inhaled nitric oxygen directly into the lungs often improves blood oxygen levels and allows caretakers to reduce the amount of oxygen given to the baby. the purpose of this research study is to evaluate if giving the inhaled nitric oxide earlier in the course of disease improves the effectiveness of the drug, reduces the amount of cellular injury from oxygen exposure, and decreases the total amount of time a patient requires supplemental oxygen. this study uses an fda approved drug in a new manner.


Eligibility criteria:
inclusion criteria: * gestational age ≥ 35 weeks gestation * age of life ≤ 48 hours * diagnosis of hypoxic respiratory failure (hrf) as defined by a post-ductal sao2 ≤90% in ≥50% oxygen with a peep of ≥ 6cm or an oxygenation index (oi) ≥ 10 but ≤ 15 when mean airway pressure and pao2 are known. * mothers (ages 18 - 65) of eligible subjects for additional data collection exclusion criteria: * gestational age \< 35 weeks gestation. * post-natal age \> 48 hours. * previous treatment with 100% oxygen for longer than 4 hours. * confirmed congenital diaphragmatic hernia. * suspected or confirmed congenital airway or pulmonary anomaly. * suspected or confirmed chromosomal anomaly or genetic aberration, with the exception of patients with trisomy 21 who do not have complex congenital heart disease. * infants with pneumothorax as the primary cause of their hrf. * infants with confirmed complex congenital heart disease.

Keywords: persistent fetal circulation syndrome infant, newborn nitric oxide oxidative stress endothelin 1 vascular endothelial growth factor
the safety and efficacy of psilocybin in participants with treatment resistant depression

Conditions: Treatment Resistant Depression

Summary: the safety and efficacy of psilocybin in participants with treatment resistant depression

the safety and efficacy of psilocybin in participants with treatment resistant depression - a dose-ranging study

Eligibility criteria:
inclusion criteria: * diagnosis of trd exclusion criteria: * other comorbidities
phase angle as a marker of muscle damage, muscle fatigue and inflammation, after eccentric exercise

Conditions: Phase Angle

Summary: the purpose of this study will be to assess the effectiveness of bioimpedance device (bia) as a safe, rapid, and non-invasive method of analyzing muscle damage induced by high intensity induced eccentric exercise as an alternative measurement tool against traditional assessment methods. a sample of 28 sedentary subjects will be recruited, all participants will perform an eccentric exercise protocol. measurements will be done before performing the exercise protocol, immediately after finishing the protocol, 3h after the end of the exercise protocol, 24h after the end of the exercise protocol and 48h after the end of the exercise protocol. the variables analyzed in all subjects will be phase angle, creatinkinase, jumping strength, vas scale, white blood count cell, quadriceps muscle thickness, borg scale and anxiety and depression questionnaires.


Eligibility criteria:
inclusion criteria: * healthy subjets * sedentary subjects exclusion criteria: * trained subjects * subjects with musculoskeletal pathology * previous surgeries in the last 6 months * subjects under pharmacological treatment
cardiopulmonary monitoring in lung cancer patients receiving combined thoracic radiotherapy and immunotherapy

Conditions: Lung Cancer

Summary: the overall purpose of this study is to evaluate cardiopulmonary toxicity in patients with lung cancer (nsclc or sclc) undergoing combined thoracic radiotherapy ± chemotherapy and immunotherapy through timed monitoring and blood sample collection and to identify correlative biomarkers for predicting cardiopulmonary adverse events.

this aims to collect observational data that describe clinical (primary endpoint) and subclinical (secondary endpoint) cardiopulmonary toxicities from combined thoracic radiotherapy and immunotherapy up to 25 months after thoracic radiotherapy and 12 months after consolidation immunotherapy among patients with locally advanced lung cancer.

Eligibility criteria:
inclusion criteria: * patient older than 18 years age * diagnosis of locally advanced lung cancer (nsclc or sclc) with planned curative radiotherapy (45gy and above) and planned consolidation immunotherapy. * patients who are not receiving concurrent chemotherapy and radiotherapy are eligible. * patients on a clinical trial that includes thoracic radiotherapy and immunotherapy are eligible and may be co-enrolled to this study. * ecog performance status of 0-2 * life expectancy of 6 months or longer * patient able to provide a written informed consent prior to study entry exclusion criteria: * prior thoracic radiotherapy to chest. * patients are excluded if they are not candidates for curative thoracic radiotherapy or immunotherapy. * other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
a registry study of participants with multiple myeloma in latin america

Conditions: Multiple Myeloma

Summary: the purpose of this study is to characterize the multiple myeloma (mm) population concerning demographics and clinical characteristics (for example. frailty, risk strata, manifestations of target organ damage \[tod\]) in 6 countries (that is argentina, brazil, mexico, chile, colombia and panama); and to profile the treatment landscape of latin american mm participants, including factors associated with health-care provider (hcp) selections of different treatment regimens. these factors can include a participant's demographic and clinical characteristics and availability of different therapy options per institution in each country.


Eligibility criteria:
inclusion criteria: * incident diagnosis of mm between 01 january 2016 and 31 december 2020 (that is the first observed diagnosis noted in the medical charts) * an informed-consent form (icf) or participation agreement must be signed before any data are collected only if a waiver is not permissible. for deceased participants who did not provide consent before death, the permission to research on their information should satisfy the local requirements (that each study site's ethics committee and each country's regulatory authority) exclusion criteria: * failed to satisfy one or more of the foregoing inclusion criteria or * only with diagnosis of smouldering myeloma between 01 january 2016 and 31 december 2020 in the medical charts
gliomaspcv only in 1p/19q codeleted anaplastic gliomas

Conditions: Anaplastic Gliomas With 1p/19q Codeletion

Summary: patients with 1p/19q-codeleted anaplastic gliomas treated with rt + pcv are at risk of neurocognitive deterioration. treating these patients with pcv alone (could reduce the risk of neurocognitive deterioration without impairing overall survival.

multicentric, randomized phase iii study (1:1), population: newly diagnosed 1p/19-codeleted anaplastic gliomas, primary objective: to determine whether treating newly diagnosed 1p/19q-codeleted anaplastic gliomas with pcv alone can increase overall survival without neurocognitive deterioration control group: radiotherapy followed by 6 cycles of pcv chemotherapy. experimental group: 6 cycles of pcv chemotherapy (radiotherapy being deferred at the time of progression). number of centres participating: the 33 centers of the pola network recruitment duration: 7 years, the accrual rate being 40 patients per year, and patients are followed-up until the end of the trial.

Eligibility criteria:
inclusion criteria : histological confirmation of anaplastic glioma by central pathological review * tumor is co-deleted for 1p and 19q * age ≥ 18 years of age * newly diagnosed and ≤3 months from surgical diagnosis * willing and able to complete neurocognitive examination and the qol * karnofsky performance status ≥ 60 * the following laboratory values obtained ≤ 21 days prior to registration: * absolute neutrophil count (anc) ≥1500 /mm3 * platelet count ≥100,000 / mm3 * hemoglobin \> 9.0 g/dl * total bilirubin ≤ 1.5 x upper limit of normal (uln) * sgot (ast) ≤ 3 x uln * negative serum or urine pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. * provide informed written consent exclusion criteria : * pregnant and nursing women * men or women of childbearing potential who are unwilling to employ adequate contraception during this study and for up to 6 months following the completion of pcv. * received any prior radiation therapy or chemotherapy for any cns neoplasm.

Keywords: chemotherapy pcv radiotherapy post operative treatment anaplastic gliomas 1p/19q codeletion cognition